Radioprotectors and Radiomitigators for Improving Radiation Therapy: The Small Business Innovation Research (SBIR) Gateway for Accelerating Clinical Translation.
Radioprotectors and Radiomitigators for Improving Radiation Therapy: The Small Business Innovation Research (SBIR) Gateway for Accelerating Clinical Translation.
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DOI：
10.1667/rr14186.1
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发表时间：
2015-09
影响因子：
3.4
通讯作者：
Coleman CN
中科院分区：
文献类型：
--
作者：
Prasanna PG;Narayanan D;Hallett K;Bernhard EJ;Ahmed MM;Evans G;Vikram B;Weingarten M;Coleman CN
尽管放射治疗是一种重要的癌症治疗方式，但患者可能会遭受不良反应。使用放射效应调节剂可以通过增强肿瘤细胞杀伤或保护正常组织来帮助改善接受放射治疗的患者的结果和健康相关的生活质量（HRQOL）。从历史上看，由于学术界、制药公司和诊所之间缺乏重点合作，以及对此类企业的支持有限，辐射效应调节剂向临床的成功转化一直受到阻碍。美国政府一直在制定针对意外和故意辐射暴露的医疗对策，以减轻急性辐射综合征（ARS）的风险和/或严重程度以及急性辐射暴露的延迟效应（DEARE），目前已经建立了药物开发渠道。其中一些医疗对策可能会被重新用于改善放射治疗的结果和癌症患者的 HRQOL。为了开发辐射效应调节剂以改善放射治疗，美国国家癌症研究所 (NCI) 的小企业创新研究 (SBIR) 发展中心在辐射研究计划 (RRP) 的支持下，于 2011 年至 2014 年通过 SBIR 合同机制向企业提供资金。虽然辐射效应调节剂统指辐射防护剂、辐射缓解剂和辐射增敏剂，但本文的重点是辐射防护和减轻辐射损伤。这一特定的 SBIR 合同机会加强了现有的合作伙伴关系，并促进了学术界和工业界之间的新合作。在这篇评论中，我们评估了这一融资机会的影响，概述了审查过程，强调了临床上开发辐射效应调节剂的器官/部位特定疾病的需求，提供了对收集临床前和临床证据以获得监管批准的框架的总体了解，并为更广泛的风险投资需求和制药公司的支持提供了基础，以充分利用该领域迄今为止取得的进展。
Although radiation therapy is an important cancer treatment modality, patients may experience adverse effects. The use of a radiation-effect modulator may help improve the outcome and health-related quality of life (HRQOL) of patients undergoing radiation therapy either by enhancing tumor cell killing or by protecting normal tissues. Historically, the successful translation of radiation-effect modulators to the clinic has been hindered due to the lack of focused collaboration between academia, pharmaceutical companies and the clinic, along with limited availability of support for such ventures. The U.S. Government has been developing medical countermeasures against accidental and intentional radiation exposures to mitigate the risk and/or severity of acute radiation syndrome (ARS) and the delayed effects of acute radiation exposures (DEARE), and there is now a drug development pipeline established. Some of these medical countermeasures could potentially be repurposed for improving the outcome of radiation therapy and HRQOL of cancer patients. With the objective of developing radiation-effect modulators to improve radiotherapy, the Small Business Innovation Research (SBIR) Development Center at the National Cancer Institute (NCI), supported by the Radiation Research Program (RRP), provided funding to companies from 2011 to 2014 through the SBIR contracts mechanism. Although radiation-effect modulators collectively refer to radioprotectors, radiomitigators and radiosensitizers, the focus of this article is on radioprotection and mitigation of radiation injury. This specific SBIR contract opportunity strengthened existing partnerships and facilitated new collaborations between academia and industry. In this commentary, we assess the impact of this funding opportunity, outline the review process, highlight the organ/site-specific disease needs in the clinic for the development of radiation-effect modulators, provide a general understanding of a framework for gathering preclinical and clinical evidence to obtain regulatory approval and provide a basis for broader venture capital needs and support from pharmaceutical companies to fully capitalize on the advances made thus far in this field.